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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011888-37 | EudraCT Number |
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This study is designed to evaluate the efficacy and safety of zoledronic acid 5 mg intravenous (i.v.) relative to placebo in Multiple Sclerosis (MS) patients with osteoporosis and to support the optimal use of zoledronic acid for this indication. Primary objective is the change of Bone Mineral Density (BMD) at lumbar spine (L1-L4) and total hip region assessed by T-Score at month 12 relative to screening as measured by Dual X-ray Absorptiometry (DXA). This double-blind period will be followed by a 52-week open-label treatment phase to assess long-term efficacy and safety of zoledronic acid in these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronic Acid | Experimental | Participants received zoledronic acid infusion in addition to calcium and vitamin D |
|
| Placebo | Placebo Comparator | Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid | Drug | Zoledronic acid 5 mg once a year via intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Mineral Density of the Lumbar Spine at 12 Months | Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | Screening (day -21 to -1) and month 12 |
| Change in Bone Mineral Density of the Total Hip Region at 12 Months | Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | Screening (day -21 to -1) and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Mineral Density of the Lumbar Spine at 6 Months | Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | Screening (day -21 to -1) and month 6 |
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Inclusion:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bamberg | Germany | ||||
| Novartis Investigative Site |
Not provided
168 participants were planned to be randomized. 29 participants were randomized in a 2:1 ratio (zoledronic acid : placebo); no participants completed the study. One participant withdrew consent and the study was terminated.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zoledronic Acid | Participants received zoledronic acid infusion in addition to calcium and vitamin D |
| FG001 | Placebo | Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zoledronic Acid | Participants received zoledronic acid infusion in addition to calcium and vitamin D |
| BG001 | Placebo | Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Bone Mineral Density of the Lumbar Spine at 12 Months | Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. | Posted | Screening (day -21 to -1) and month 12 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zoledronic Acid | Participants received zoledronic acid infusion in addition to calcium and vitamin D |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LOSS OF CONSCIOUSNESS | Nervous system disorders | 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | 15.1 | Systematic Assessment |
Study termination due to small number of participants recruited lead to lack of power for analysis of all outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 41 61 324 1111 |
Not provided
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| D002118 | Calcium |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
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| Placebo |
| Drug |
Placebo to zoledronic acid once a year via intravenous infusion |
|
| Calcium and Vitamin D combination | Dietary Supplement | Calcium 500 mg and Vitamin D 400 IU combined tablet, taken orally twice a day |
|
| Change in Bone Mineral Density of the Femoral Neck at 6 Months |
Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. |
| Screening (day -21 to -1) and month 6 |
| Change in Bone Mineral Density of the Total Hip at 6 Months | Change in bone mineral density (BMD) of the total hip was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | Screening (day -21 to -1) and month 6 |
| Change in Bone Mineral Density of the Femoral Neck at 12 Months | Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | Screening (day -21 to -1) and month 12 |
| Change in Bone Mineral Density of the Lumbar Spine at 24 Months | Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | Screening (day -21 to -1) and month 24 |
| Change in Bone Mineral Density of the Total Hip Region at 24 Months | Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | Screening (day -21 to -1) and month 24 |
| Change in Bone Mineral Density of the Femoral Neck at 24 Months | Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | Screening (day -21 to -1) and month 24 |
| Course of Disease in Multiple Sclerosis Patients | The course of disease in Multiple Sclerosis (MS) patients was measured comparing results from the Expanded Disability Status Scale (EDSS) from screening and month 12. EDSS is a scale, ranging from 0 (normal) to 10 (death due to MS) for assessing neurologic impairment in MS. It is based on a weighting scheme of eight functional systems. The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel&Bladder, Cerebral and Other functions. EDSS was assessed by the treating neurologist. | Screening (day -21 to -1) and month 12 |
| Adverse Events and Serious Adverse Events Comparison of Treatment Groups | Adverse Events and Serious Adverse events are reported in the safety section. | 24 months |
| Berlin |
| Germany |
| Novartis Investigative Site | Bochum | Germany |
| Novartis Investigative Site | Hamburg | Germany |
| Novartis Investigative Site | Heidelberg | Germany |
| Novartis Investigative Site | Kassel | Germany |
| Novartis investigative site | Leipzig | Germany |
| Novartis Investigative Site | Leverkusen | Germany |
| Novartis investigative site | Ludwigshafen | Germany |
| Novartis investigative site | Magdeburg | Germany |
| Novartis investigative site | München | Germany |
| Novartis investigative site | Nümbrecht | Germany |
| Novartis investigative site | Oldenburg | Germany |
| Novartis Investigative Site | Siegen | Germany |
| Novartis investigative site | Stade | Germany |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D |
|
| Secondary | Change in Bone Mineral Density of the Lumbar Spine at 6 Months | Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. | Posted | Screening (day -21 to -1) and month 6 |
|
|
| Secondary | Change in Bone Mineral Density of the Femoral Neck at 6 Months | Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. | Posted | Screening (day -21 to -1) and month 6 |
|
|
| Secondary | Change in Bone Mineral Density of the Total Hip at 6 Months | Change in bone mineral density (BMD) of the total hip was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 6. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. | Posted | Screening (day -21 to -1) and month 6 |
|
|
| Secondary | Change in Bone Mineral Density of the Femoral Neck at 12 Months | Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. | Posted | Screening (day -21 to -1) and month 12 |
|
|
| Secondary | Change in Bone Mineral Density of the Lumbar Spine at 24 Months | Change in bone mineral density (BMD) of the lumbar spine was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. | Posted | Screening (day -21 to -1) and month 24 |
|
|
| Primary | Change in Bone Mineral Density of the Total Hip Region at 12 Months | Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 12. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. | Posted | Screening (day -21 to -1) and month 12 |
|
|
| Secondary | Change in Bone Mineral Density of the Total Hip Region at 24 Months | Change in bone mineral density (BMD) of the total hip region was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. | Posted | Screening (day -21 to -1) and month 24 |
|
|
| Secondary | Change in Bone Mineral Density of the Femoral Neck at 24 Months | Change in bone mineral density (BMD) of the femoral neck was measured using Dual X-ray Absorptiometry (DXA) at screening and at month 24. A DXA scanner is a device that uses x-ray beams to measure the amount of minerals in the bone. | A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. | Posted | Screening (day -21 to -1) and month 24 |
|
|
| Secondary | Course of Disease in Multiple Sclerosis Patients | The course of disease in Multiple Sclerosis (MS) patients was measured comparing results from the Expanded Disability Status Scale (EDSS) from screening and month 12. EDSS is a scale, ranging from 0 (normal) to 10 (death due to MS) for assessing neurologic impairment in MS. It is based on a weighting scheme of eight functional systems. The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel&Bladder, Cerebral and Other functions. EDSS was assessed by the treating neurologist. | A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. | Posted | Screening (day -21 to -1) and month 12 |
|
|
| Secondary | Adverse Events and Serious Adverse Events Comparison of Treatment Groups | Adverse Events and Serious Adverse events are reported in the safety section. | A total of 168 randomized participants were needed to have a power of 93% % to detect a significant difference in lumbar spine BMD. This study randomized 29 participants of the planned 168; hence, the planned analysis was not done. The sample size was not powered for comparison between groups; however, all AEs are reported in the safety section. | Posted | 24 months |
|
|
| 2 |
| 21 |
| 16 |
| 21 |
| EG001 | Placebo | Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D | 0 | 8 | 5 | 8 |
| MULTIPLE SCLEROSIS | Nervous system disorders | 15.1 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | 15.1 | Systematic Assessment |
|
| FATIGUE | General disorders | 15.1 | Systematic Assessment |
|
| GAIT DISTURBANCE | General disorders | 15.1 | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | 15.1 | Systematic Assessment |
|
| PYREXIA | General disorders | 15.1 | Systematic Assessment |
|
| ARTHROPOD BITE | Injury, poisoning and procedural complications | 15.1 | Systematic Assessment |
|
| WHITE BLOOD CELLS URINE POSITIVE | Investigations | 15.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
|
| BONE PAIN | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | 15.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | 15.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | 15.1 | Systematic Assessment |
|
| MULTIPLE SCLEROSIS RELAPSE | Nervous system disorders | 15.1 | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | 15.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | 15.1 | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D009750 |
| Nutritional and Metabolic Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |